医学
多西紫杉醇
环磷酰胺
乳腺癌
发热性中性粒细胞减少症
内科学
化疗
中性粒细胞减少症
优势比
肿瘤科
临床终点
胃肠病学
置信区间
外科
癌症
随机对照试验
作者
Birgit E. P. J. Vriens,Maureen J.B. Aarts,Bart de Vries,Saskia M. van Gastel,J. Wals,Tineke J. Smilde,L. J. C. van Warmerdam,Maaike de Boer,D.J. van Spronsen,George F. Borm,Vivianne C. G. Tjan‐Heijnen
标识
DOI:10.1016/j.ejca.2013.06.012
摘要
Background This study was designed to determine whether delivering neo-adjuvant chemotherapy at a higher dose in a shorter period of time improves outcome of breast cancer patients. Patients and methods Women with newly diagnosed breast cancer were randomly assigned to neoadjuvant chemotherapy of four cycles of doxorubicin and cyclophosphamide followed by four cycles of docetaxel (AC 60/600 – T 100 mg/m2) or six cycles of TAC (75/50/500 mg/m2) every 3 weeks. The primary endpoint was the pathologic complete response (pCR) rate, defined as no invasive tumour present in the breast. Results In total, 201 patients were included. Baseline characteristics were well balanced. AC-T resulted in pCR in 21% and TAC in 16% of patients (odds ratio 1.44 (95% confidence interval (CI) 0.67–3.10). AC-T without primary granulocyte-colony stimulating factor (G-CSF) prophylaxis was associated with more febrile neutropenia compared to TAC with primary G-CSF prophylaxis (23% versus 9%), and with more grade 3/4 sensory neuropathy (5% versus 0%). Conclusions With a higher cumulative dose for the concurrent arm, no differences were observed between the two treatment arms with respect to pCR rate. The differential toxicity profile could partly be explained by different use of primary G-CSF prophylaxis.
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